EORTC brain tumor group study 26971: first line chemotherapy with temozolomide in recurrent oligodendroglial tumors a phase II study
Temador used as first chemotherapy for recurrent oligodendroglial tumors showed 54% partial response; phase III study to compare temador to PCV is indicated.
Posted on: 05/26/2002
EORTC brain tumor group study 26971: first line chemotherapy with temozolomide in recurrent oligodendroglial tumors; a phase II study
Martin J van den Bent, M J Taphoorn, A A Brandes, J Menten, R Stupp, M Frenay, C C van der Rijt, J M Kros, A Allgeier, T Gorlia, Rotterdam Cancer Center, Rotterdam, Netherlands; University Hospital Utrecht, Utrecht, Netherlands; Azienda Ospedale, Padova, Italy; U.Z. Gasthuisberg, Leuven, Belgium; University Hospital CHUV, Lausanne, Switzerland; Centre Antoine Lacassagne, Nice, France; University Hospital Rotterdam, Rotterdam, Netherlands; EORTC Data Center, Brussels, Belgium.
Introduction. Oligodendroglial tumors (OD) are chemosensitive tumors, with 60-70% of patients (pts) responding to the PCV schedule. Recent studies have shown the efficacy of temozolomide (TMZ) in astrocytic tumors. We investigated first line temozolomide chemotherapy in pts with recurrent and contrast enhancing oligodendroglial tumors after prior radiation therapy. Objectives. Response rate, time to progression and toxicity of TMZ in recurrent oligodendroglial tumors.
Methods. Prospective multicenter trial. Eligible were pts with recurrent OD after RT with a contrast enhancing tumor with a diameter >1cm. No prior chemotherapy was allowed. Pts were treated with 200 mg/m2 TMZ on day 1-5, q 28 days. A partial response was defined as a 50% decrease in contrast enhancing area on 2 consecutive scans taken at least 1 month apart. As part of the study histology review of all patients and response review of all responding patients were done. Toxicity was assessed with the CTC criteria.
Results. 39 pts were included, median age 49 yrs. A total of 310 cycles TMZ were administered (median 8). At review 3 pts had other histologies (in 3 review is still pending). 1 pt refused treatment leaving 35 pts evaluable for response: 9 complete response, 10 partial response, 10 no change (objective response rate 54%). At 12 months 49% of all pts were still free from progression. Toxicity was mainly hematological, with a grade 3 leukopenia or thrombopenia in 7 pts, and a grade 4 in 3 pts. Other grade 3/4 side effects: grade 3 nausea and vomiting in 2 pts, lethargy/malaise in 1 and hypertension in 1. Two pts had to discontinue treatment for severe but reversible toxicity.
Conclusions. Temozolomide shows a significant activity as first line chemotherapy in recurrent oligodendroglial tumors, and is usually well tolerated. A phase III trial comparing temozolomide to PCV is indicated.
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